Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
nitroprusside, ketones (urinary, non-quant.)
Product Code
JIN
Regulation Number
862.1435
Device Class
1
Premarket Reviews
Manufacturer
Decision
ACON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
APEX BIOTECHNOLOGY CORP.
SUBSTANTIALLY EQUIVALENT
1
I-SENS, INC.
SUBSTANTIALLY EQUIVALENT
2
TAIDOC TECHNOLOGY CORPORATION
SUBSTANTIALLY EQUIVALENT
1
VIVACHEK BIOTECH (HANGZHOU) CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2018
5
5
2019
52
52
2020
37
37
2021
43
43
2022
14
14
2023
17
17
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Discolored
61
61
No Device Output
41
41
Unsealed Device Packaging
20
20
Display Difficult to Read
14
14
Ambient Temperature Problem
10
10
Manufacturing, Packaging or Shipping Problem
9
9
Incorrect, Inadequate or Imprecise Result or Readings
9
9
Unable to Obtain Readings
8
8
Product Quality Problem
4
4
Labelling, Instructions for Use or Training Problem
4
4
Defective Device
4
4
Unexpected Color
4
4
Insufficient Information
2
2
Incorrect Measurement
2
2
High Test Results
2
2
Device Emits Odor
1
1
Output Problem
1
1
Device Markings/Labelling Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Integrity Problem
1
1
Contamination
1
1
Appropriate Term/Code Not Available
1
1
Overheating of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
53
53
No Consequences Or Impact To Patient
52
52
No Known Impact Or Consequence To Patient
46
46
Insufficient Information
14
14
Diabetic Ketoacidosis
3
3
Vomiting
3
3
Fatigue
2
2
Dizziness
2
2
Headache
2
2
No Code Available
1
1
Nausea
1
1
Injury
1
1
Lethargy
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Diabetes Care, Inc.
II
Feb-28-2020
2
Cardinal Health Inc.
II
May-20-2020
3
MEDLINE INDUSTRIES, LP - Northfield
II
Apr-14-2022
4
Medline Industries Inc
II
Apr-09-2021
5
Stanbio Laboratory, LP
II
Dec-06-2023
6
Stanbio Laboratory, LP
III
Aug-05-2021
7
Universal Meditech Inc.
II
Oct-23-2023
-
-